# PTC: Uric Acid Test System For At Home Prescription Use

- Device class: 1; regulation: 21 CFR 862.1775; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 249 days (middle half 249–249)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 1
- 2018: 1
- 2025: 1

## Most-cited predicates
- K160990: Nova Max Uric Acid Monitoring System (2017), cited by 1

Source page: https://510kreport.com/product-code/PTC
Data by year (CSV): https://510kreport.com/product-code/PTC.csv